Manager/Sr. Manager, Statistical Programming

Eidos San Francisco, CA/Hybrid Biostatistics & Data Management

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About Eidos Therapeutics & BridgeBio Pharma

Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a Phase 3 developmental-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our investigational product, acoramidis (AG10), is an orally administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs. 

Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe. 

To learn more about our story and company culture, visit us at eidostx.com/ | https://bridgebio.com

Who You Are

The Manager/Sr. Manager, Statistical Programming is a member of the Biostatistics team and is an individual contributor in charge of SAS programming production and validation activities. Responsibilities include CSR programming, review of standard study documents, and ensuring study and database integrity.

Responsibilities

  • Study lead programmer to oversee CRO and in-house programming deliverables and milestones from study start-up to study completion, following programming standards and ensuring compliance with SOPs to produce high quality and timely deliverables
  • Work closely with study programmers in all aspects of the development of the Statistical Programming deliverables and anticipate high-risk activities
  • Provide technical expertise to the development of programming SOP’s
  • Review Protocol, Statistical Analysis Plan, DTS, TFL shells and update standard SDTM/ADaM specifications following the IG version and tailor it to the study goals and analysis needs
  • Ability to generate and review the TFL’s, XPT files, define.xml, cSDRG, ADRG and aCRF for submission to various regulatory agencies
  • Manage multiple ad hoc requests simultaneously, update project timelines and prioritized tasks for study programmers for effectively completing various requests and within timelines
  • Work with CRO to understand their preferences and limitations and provide guidance on the timelines and quality of the deliverables
  • Address any programming concerns raised by CRO during study, including study timelines, data transfer issues, data mapping issues, addressing P21 issues etc.
  • Provide guidance to Direct reports to review the study documents (SAP, TFL Shells, DQRP, DTS, sDVS etc) from a programming perspective during study setup and prepare them to Lead studies
  • Collaborate with cross-functional teams, including biostatistics, data management, and clinical operations, to ensure accurate and timely delivery of programming deliverables
  • Lead study programming activities and ability to prepare for study milestones and propose solutions for high-risk activities

No matter your role at BridgeBio, successful team members are:

  • Patient Champions, who put patients first and uphold strict ethical standards
  • Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
  • Truth Seekers, who are detailed, rational, and humble problem solvers
  • Individuals Who Inspire Excellence in themselves and those around them
  • High-quality executors, who execute against goals and milestones with quality, precision, and speed

Education, Experience & Skills Requirements

  • MS (or equivalent degree) with 5+ years or BS with 8+ years of relevant work experience in clinical research, as a SAS programmer for phase I-IV clinical trials in a Biotech, Pharma, Clinical Research Organizations, or other relevant organizations
  • Highly competent with SAS language and procedures commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
  • Excellent organizational skills with strong attention to detail and the ability to multi-task and manage multiple studies
  • Excellent verbal and written communication skills are required
  • NDA submission experience is a plus
  • Experience working with CROs, vendors, and supervising programmers

What We Offer

  • Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
  • A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
  • An unyielding commitment to always putting patients first. Learn more about how we do this here
  • A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
  • A place where you own the vision – both for your program and your own career path
  • A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
  • Access to learning and development resources to help you get in the best professional shape of your life
  • Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
  • Flexible PTO
  • Rapid career advancement for strong performers
  • Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time 
  • Partnerships with leading institutions
  • Commitment to Diversity, Equity & Inclusion
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
Salary
$142,000$190,000 USD

careers

Manager/Sr. Manager, Statistical Programming

Eidos San Francisco, CA/Hybrid Biostatistics & Data Management

Apply Now